Sterility Assurance Program Lead — Senior Consultant

ProPharma; Raleigh (NC); On-site; USD 120,000 - 170,000; Part time

Benefits offered by this job

Hybrid work model

Equal opportunity employer

Job summary

ProPharma in Kansas City, KS seeks a senior lead for retrospective product reviews, focusing on sterility reviews, protocol development, and client communication. You will oversee a small team, coordinate cross-functional tasks, and ensure scientific rigor in the assessment of lot data and product impact.

The role requires 10+ years in sterile manufacturing with aseptic processing experience and FDA remediation knowledge.

Qualifications

• Experience leading sterile manufacturing and sterility assurance initiatives.
• Strong understanding of aseptic processing and regulatory remediation.
• Proven ability to oversee technical reviews and client communications.

Responsibilities

• Lead the sterility review team (2-3 people) and act as the primary client contact.
• Develop and finalize the review protocol and assessment methodology.
• Coordinate execution of retrospective review and deliverables.
• Provide technical oversight and review of lot assessments and product impact conclusions.
• Facilitate escalation of significant product-quality concerns and governance meetings.

Skills

Sterile manufacturing

Sterility assurance

Aseptic processing

FDA remediation

Technical oversight

Project leadership

Job description

ProPharma in Kansas City, KS seeks a senior lead for retrospective product reviews, focusing on sterility reviews, protocol development, and client communication. You will oversee a small team, coordinate cross-functional tasks, and ensure scientific rigor in the assessment of lot data and product impact.

The role requires 10+ years in sterile manufacturing with aseptic processing experience and FDA remediation knowledge.